Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma
This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.
PRIMARY OBJECTIVES:
I. To determine whether the addition of plerixafor improves the proportion of patients with
lymphoma who collect >= 8 x 10^6 cluster of differentiation (CD)34+ cells/kg within two days
by 25% compared to the historical estimate of 42% with etoposide and G-CSF (filgrastim).
II. To determine whether patients achieving collection of >= 8 x 10^6 CD34+ cells/kg have a
15% one year survival advantage relative to the historical estimate of 68% among patients
mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and G-CSF.
SECONDARY OBJECTIVES:
I. To demonstrate that patients receiving >= 8 x 10^6 CD34+ cells/kg have more rapid
neutrophil and platelet recovery and earlier hospital discharge than those receiving < 8 x
10^6 CD 34+ cells/kg.
II. To compare overall survival and progression-free survival between patients receiving >= 8
x 10^6 CD34+ cells/kg and those receiving < 8 x 10^6 CD34+ cells/kg.
III. To compare number of days of apheresis required to achieve goal, transfusion
requirements, hospitalization costs, need for remobilization between groups.
IV. To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+
cells.
OUTLINE:
Patients receive etoposide intravenously (IV) over 4 hours on day 0, filgrastim
subcutaneously (SC) once daily (QD) beginning day 1, and plerixafor SC 15-18 hours prior to
apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive
another dose of plerixafor followed by apheresis. Following the second apheresis, patients
achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue
collection according to the attending physician.
After completion of study treatment, patients are followed up at 28 days and then for at
least 1 year.
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